We are currently seeking a Validation engineer for one of our clients in Canton of Neuchatel.
If you are looking to work in a dynamic and very friendly working environment then this is for you.
This is an open-ended temporary contract
Please note this vacancy requires fluency in French.
Your responsibilities:
- Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
- Work with project teams to develop validation strategy and statistically sound tests for appropriate support of results.
- Complete test method validation, gauges R&R studies and other qualifications or studies to support product testing.
- Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.
- Develop statistically based sampling plans for in-process and final test sequencing.
- Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
- Support and address comments and suggestions associated with validation and engineering documentation.
- Protocol, Deviation, and summary report generation and approval.
- Change control, non-conformance and CAPA support.
Your profile:
- Bachelor's Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
- 2 to 5 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
- Fluency in French and good command of English
- Demonstrates excellent organizational and communication skills.
- Experience with qualifying medical devices, manufacturing equipment or external components.
- Excellent technical writing skills with a thorough understanding of good documentation practice.
- Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.
- Use of Microsoft office tools
- Knowledges of statistical techniques